Fentora

Fentora

Fentora

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800 mcg, round, white, imprinted with LOGO, 8

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What is the most important information I should know about fentanyl buccal/sublingual?

Fentanyl can slow or stop your breathing, and may be habit-forming. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Do not use this medicine unless you are already using an around-the-clock opioid medicine and are tolerant to it.

Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

What is fentanyl buccal/sublingual?

Fentanyl is an opioid pain medication, sometimes called a narcotic. Fentanyl buccal or sublingual products are used in the mouth but not swallowed whole. Fentanyl buccal is placed inside the mouth between the cheek and gum. Fentanyl sublingual is placed under the tongue.

Fentanyl buccal/sublingual is used to treat "breakthrough" cancer pain that is not controlled by other medicines. This medicine is not for treating pain that is not cancer-related.

Fentanyl buccal/sublingual may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using fentanyl buccal/sublingual?

Do not use fentanyl unless you are already using an around-the-clock opioid medicine and are tolerant to it. You should not use fentanyl if you are allergic to it, or if you have:

severe asthma or other breathing problems; or

a stomach or bowel obstruction (including paralytic ileus).

To make sure this medicine is safe for you, tell your doctor if you have ever had:

Tell your doctor if there are children living in the home where you will store this medicine. The amount of fentanyl in this medicine can be fatal to a child.

If you use fentanyl while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breast-feed while you are using this medicine.

How should I use fentanyl buccal/sublingual?

Follow all directions on your prescription label. Fentanyl can slow or stop your breathing. Never use this medicine in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

If you have been using another form of fentanyl (injection, skin patch, "lollipop" device), your buccal or sublingual dose may be different.

Fentanyl may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away fentanyl is against the law.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Use only 1 tablet at a time. If your pain does not go away completely, use a second tablet only if your doctor has approved it.

You must wait at least 2 hours after your last dose of Abstral before you can treat a new pain episode. You must wait at least 4 hours after your last dose of Fentora or Subsys before you can treat a new pain episode.

Call your doctor if you have breakthrough pain more than 4 times in one day while using this medicine. Do not treat more than 4 pain episodes per day with this medicine.

Do not stop using fentanyl suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using fentanyl.

Never crush or break a fentanyl pill to inhale the powder or mix it into a liquid to inject the drug into your vein.

Store at room temperature away from moisture and heat. Do not freeze. Keep your medicine in a place where others cannot get to it. Fentanyl is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Keep this medicine out of the reach of children or pets. The amount of fentanyl in each buccal or sublingual product can be fatal to a child or pet who accidentally sucks on or swallows it. Seek emergency medical attention if this happens.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, throw away any unused fentanyl tablets by removing them from the blister pack and flushing them down a toilet. Dispose of used sublingual spray units in the disposal bags provided with the medicine. Empty any unused spray units into the disposal bottle provided.

What happens if I miss a dose?

Since fentanyl is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A fentanyl overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include extreme weakness or drowsiness, weak pulse, cold and clammy skin, pinpoint pupils, and slow breathing (breathing may stop).

What should I avoid while using fentanyl buccal/sublingual?

This medicine may impair your thinking or reactions. Avoid driving or operating machinery until you know how fentanyl will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Do not drink alcohol. Dangerous side effects or death could occur.

Grapefruit and grapefruit juice may interact with fentanyl and lead to unwanted side effects. Avoid the use of grapefruit products while taking fentanyl.

What are the possible side effects of fentanyl buccal/sublingual?

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Like other narcotic medicines, fentanyl can slow your breathing. Death may occur if breathing becomes too weak. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Serious side effects may be more likely in older adults and those who are malnourished or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common side effects may include:

headache, dizziness, drowsiness, pale skin, feeling weak or tired;

constipation, nausea, vomiting; or

swelling in your hands or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect fentanyl buccal/sublingual?

Some drugs can raise or lower your blood levels of fentanyl, which may cause side effects or make fentanyl less effective. Tell your doctor if you also use certain antibiotics, antifungal medications, heart or blood pressure medications, or medicines to treat HIV or AIDS.

Fentanyl can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

This list is not complete. Other drugs may interact with fentanyl, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your pharmacist can provide more information about fentanyl buccal/sublingual.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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